Nanosphere, Inc. is one of 13015 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Nanosphere, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex), VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP), VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
16
Total
15
Cleared
1
Denied
Nanosphere, Inc. has 15 FDA 510(k) cleared microbiology devices. Based in Northbrook, US.
Historical record: 15 cleared submissions from 2007 to 2015.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by MDC Associates, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Nanosphere, Inc.
16 devices
Cleared
Sep 04, 2015
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex)
Microbiology
255d
Cleared
Jun 20, 2014
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
Microbiology
158d
Cleared
Jan 08, 2014
VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN)
Microbiology
120d
Cleared
Dec 05, 2012
VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)
Microbiology
55d
Cleared
Nov 06, 2012
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
Toxicology
265d
Cleared
Sep 19, 2012
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
Microbiology
33d
Not Cleared
Jun 26, 2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
Microbiology
11d
Cleared
Dec 16, 2011
VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)
Microbiology
115d
Cleared
Jan 10, 2011
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)
Microbiology
70d
Cleared
Nov 17, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM
Microbiology
22d
Cleared
Oct 21, 2009
VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST
Microbiology
26d
Cleared
Oct 09, 2009
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP)
Microbiology
50d